NDC 11523-7448 Coppertone Ultra Guard Spf 50

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 11523-7448

NDC CODE: 11523-7448

Proprietary Name: Coppertone Ultra Guard Spf 50 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Homosalate, Octisalate, Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 11523 - Bayer Healthcare Llc.

NDC 11523-7448-1

Package Description: 45 g in 1 CAN

NDC Product Information

Coppertone Ultra Guard Spf 50 with NDC 11523-7448 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Coppertone Ultra Guard Spf 50 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Bayer Healthcare Llc.

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Coppertone Ultra Guard Spf 50 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE 30 mg/g
  • HOMOSALATE 100 mg/g
  • OCTOCRYLENE 50 mg/g
  • OCTISALATE 50 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • ALCOHOL (UNII: 3K9958V90M)
  • ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
  • ISOBUTANE (UNII: BXR49TP611)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bayer Healthcare Llc.
Labeler Code: 11523
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 09-01-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Coppertone Ultra Guard Spf 50 Product Label Images

Coppertone Ultra Guard Spf 50 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Otc - Active Ingredient

Active ingredients (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Otc - Purpose

PurposeSunscreen

Uses

Uses■ helps prevent sunburn■ if used as directed with other sun protection measures (see
Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WarningsFor external use onlyFlammable: Do not use near heat, flame, or while smoking

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product■ keep out of eyes. Rinse with water to remove.■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions■ shake well before each use■ apply liberally 15 minutes before sun exposure and rub into skin■ do not spray directly on face. Spray into hands and apply to face■ use in well-ventilated areas■ reapply:■ after 80 minutes of swimming or sweating■ immediately after towel drying■ at least every 2 hours■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
■ limit time in the sun, especially from 10 a.m. – 2 p.m.■ wear long-sleeve shirts, pants, hats, and sunglasses■ children under 6 months: Ask a doctor
ions

Other Information

Other information ■ protect this product from excessive heat and direct sun■ avoid long-term storage above 40˚C (104˚F)■ may stain or damage some fabrics or surfaces

Inactive Ingredient

Inactive ingredients SD alcohol 40-B (73.8% v/v), isobutane, neopentyl glycol diheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

Otc - Questions

Questions? 1-866-288-3330

* Please review the disclaimer below.